U.S. patent number 3,742,938 [Application Number 05/103,611] was granted by the patent office on 1973-07-03 for cardiac pacer and heart pulse monitor.
Invention is credited to Theodore J. Stern.
United States Patent |
3,742,938 |
Stern |
July 3, 1973 |
CARDIAC PACER AND HEART PULSE MONITOR
Abstract
A method of and system for remote cardiac diagnosis of cardiac
patients, whether or not fitted with implanted cardiac pacer by use
of the ordinary telephone. A small transducer transmitter picks up
the patient's blood pulses, and cardiac pacer pulses if present,
electrically codes them and sends them in proper time sequence
through the ordinary telephone transmitter over the telephone lines
to a processing center where the coded signals are checked for
presence or absence and for the time intervals between adjacent
signals of the same coded type and adjacent signals of different
coded types. From this data it is possible to determine the
operating condition of the cardiac pacer, non-capture and
intermittent capture of the heart by the cardiac pacer,
cardio-vascular system hemodynamic changes, and cardiac arrhythmias
such as missing heartbeat and possible premature ventricular
contraction.
Inventors: |
Stern; Theodore J.
(Willingboro, NJ) |
Family
ID: |
22296076 |
Appl.
No.: |
05/103,611 |
Filed: |
January 4, 1971 |
Current U.S.
Class: |
600/500; 600/510;
607/27; 128/904 |
Current CPC
Class: |
A61N
1/37 (20130101); A61B 5/024 (20130101); A61B
5/0245 (20130101); A61B 5/0006 (20130101); Y10S
128/904 (20130101) |
Current International
Class: |
A61B
5/00 (20060101); A61B 5/0245 (20060101); A61B
5/024 (20060101); A61N 1/362 (20060101); A61N
1/37 (20060101); A61b 005/02 () |
Field of
Search: |
;128/2.5P,2.5RS,2.5T,2.6A,2.6F,2.6T,2.6R,2.1A,419P |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Primary Examiner: Kamm; William E.
Claims
I claim:
1. A method of cardiac diagnosis for detection of abnormal cardiac
conditions in patients remote in distance from the diagnostic
center, consisting of the steps of,
a. detecting the occurrence of each of a continuous sequence of the
patient's physiological blood pulses,
b. converting such blood pulses as they occur to a sequence of
non-analog timing signals for transmission through a commercial
telephone system and thereby generating a sequence of electrical
signals occurring in the same timed relationship to one another as
the timed relationship between the blood pulses to which they
correspond,
c. inserting the sequence of electrical signals into a commercial
telephone system and transmitting the signals to a data processing
center where the following steps are carried out,
d. detecting the timed sequence of electrical signals,
e. measuring, displaying and recording in units of time the time
interval between each successive pair of signals of the
sequence,
f. comparing the aforesaid measured time intervals against one
another, and
g. indicating the displayed time intervals and whether or not the
compared time intervals differ from one another by more than a
predetermined length of time,
whereby, conditions of cardiac arrhythmias, such as missing
heartbeat and possible premature ventricular contraction are
detectable.
2. A method of cardiac diagnosis as described in claim 1 wherein
the step of comparing the measured time intervals against one
another further includes comparing the aforesaid time intervals
against standard time intervals previously established by the
physician as normal for the particular person being monitored.
3. A method of cardiac diagnosis as described in claim 1 wherein
the step of converting each blood pulse consists of the steps of,
first converting the blood pulse to an electrical analog signal and
then converting the analog signal to a non-analog electrical signal
designating only the time of occurrence of the blood pulse.
4. A method of cardiac diagnosis as described in claim 1 wherein
the steps of converting each blood pulses consists of the steps of,
first converting the blood pulse to an electrical analog signal,
then converting the analog signal to a non-analog tone burst
electrical signal, then converting the non-analog electrical tone
burst signal to an acoustical signal within the bandpass of the
transmitter of a commercial telephone.
5. A method of cardiac diagnosis for detection of abnormal
conditions in cardiac pacer patients remote in distance from the
diagnostic center, consisting of the steps of,
a. detecting the occurrence of each of a continuous sequence of
cardiac pacer pulses, and detecting the occurrence of each of a
continuous sequence of the patient's physiological blood
pulses,
b. converting each such pacer pulse and blood pulse as it occurs to
a signal for transmission through a commercial telephone system and
thereby generating a sequence of electrical signals occurring in
the same timed relationship to one another as the timed
relationship between the pacer pulses and blood pulses to which
they correspond,
c. inserting the sequence of electrical signals into a commercial
telephone system and transmitting the signals to a data processing
center where the following steps are carried out,
d. detecting the timed sequence of electrical signals,
e. measuring the time intervals between selected pairs of signals
of the sequence,
f. comparing the aforesaid measured time intervals against one
another, and
g. indicating whether or not the compared time intervals differ
from one another by more than a predetermined length of time,
whereby, conditions of cardiac pacer failure, non-capture and
intermittent capture of the heart by the pacer, cardio-vascular
system hemodynamic changes, cardiac arrhythmias, such as missing
heartbeat, and possible premature ventricular contraction are
detectable.
6. A method of cardiac diagnosis as described in claim 5 wherein
the step of comparing the measured time intervals against one
another further includes comparing the aforesaid time intervals
against standard time intervals previously established by the
physician as normal for the particular person being monitored.
7. A method of cardiac diagnosis as described in claim 5 wherein
detecting the occurrence of the pacer pulses and detecting the
occurrence of the blood pulses are carried out independently of one
another, and wherein converting the pacer pulses and blood pulses
to a sequence of timed electrical signals includes the step of
combining the pulses into a single sequence of pulses.
8. A method of cardiac diagnosis as described in claim 5 wherein
the step of measuring the time intervals between selected pairs of
signals of the sequence includes the step of first separating the
sequence of timed electrical signals into a first sequence of
signals corresponding only to pacer pulse signals and a second
sequence of signals corresponding only to blood pulse signals.
9. A method of cardiac diagnosis as described in claim 8 wherein
the step of separating the sequence of timed electrical signals
into the aforesaid first and second sequences and selectively
following the signals separating step by one or more of the
following steps,
a. the step of measuring the time interval between each successive
pair of signals of said first sequence,
b. the step of measuring the time interval between each successive
pair of signals of said second sequence,
c. the step of measuring the time interval between each successive
pair of signals in which the first signal of the pair is selected
from said first sequence and the second signal of the pair is
selected as the next occurring signal from said second
sequence.
10. A method of cardiac diagnosis as described in claim 5 wherein
the step of measuring the time intervals between selected pairs of
signals of the sequence includes the step of first separating the
sequence of electrical signals, and selecting either or both of a
first sequence of signals corresponding only to pacer pulse signals
and a second sequence of signals corresponding only to blood pulse
signals.
11. A cardiac diagnostic system for detection of abnormal cardiac
conditions in patients located remotely from a diagnostic center,
comprising in combination,
a. a transducer transmitter comprising,
1. first detection means for detecting the occurrence of each of a
continuous sequence of the patient's physiological blood
pulses,
2. converter means operatively coupled to said first detection
means effective to convert such blood pulses as they occur to a
sequence of non-analog timing signals for transmission through a
commercial telephone system, and thereby being capable of
generating a sequence of electrical signals occurring in the same
timed relationship to one another as the timed relationship between
the blood pulses to which they correspond.
3. means adapted to be coupled to a commercial telephone system
effective to insert the said sequence of signals into a commercial
telephone system to transmit the signals to a data processing
center,
b. a receiver processer at the data processing center
comprising,
1. second detection means adapted to be coupled to a commercial
telephone system effective to detect the timed sequence of signals
inserted at the transmitting point,
2. signal presentation means coupled to said second detection means
for measuring, displaying and recording in units of time the time
intervals between successive pairs of signals of the sequence,
whereby, conditions of cardiac arrhythmias, such as missing
heartbeat, and possible premature ventricular contraction are
detectable.
12. A cardiac diagnostic system as described in claim 11 wherein
said first detection means comprises a transducer which generates a
discrete analog electrical signal upon detection of each blood
pulse, and wherein said converter means converts each of said
discrete analog electrical signal to a standardized non-analog
waveform.
13. A cardiac diagnostic system as described in claim 11 wherein
said receiver processer signal presentation means comprises
measuring means effective to automatically measure the time
intervals between successive pairs of the sequence and provide a
read-out of the measurement in units of time.
14. A cardiac diagnostic systems as described in claim 13 wherein
said measuring means read-out includes an electrical signal
read-out representing the time interval just measured, said
receiver processer further including a comparator device coupled to
said measuring means and effective responsive to said electrical
signal read-out from the latter to actuate an alarm when the time
interval represented thereby differs by more than a predetermined
amount from a standard time interval selectively programmed into
said comparator device.
15. A cardiac diagnostic system for detection of abnormal cardiac
conditions in patients located remotely from a diagnostic center,
comprising in combination,
a. a transducer transmitter comprising,
1. first detection means for detecting the occurrence of each of a
continuous sequence of cardiac pacer pulses, and detecting the
occurrence of each of a continuous sequence of the patient's
physiological blood pulses,
2. converter means operatively coupled to said first detection
means effective to convert each such pacer pulse and each such
blood pulse as it occurs to a signal for transmission through a
commercial telephone system, and thereby generating a sequence of
electrical signals occurring in the same timed relationship to one
another as the timed relationship between the pacer pulses and the
blood pulses to which they correspond,
3. means adapted to be coupled to a commercial telephone system
effective to insert the said sequence of signals into a commercial
telephone system to transmit the signals to a data processing
center,
b. a receiver processer at the data processing center
comprising,
1. second detection means, adapted to be coupled to a commercial
telephone system effective to detect the timed sequence of signals
inserted at the transmitting point,
2. signal presentation means coupled to said second detection means
for measuring, displaying and recording in units of time the time
intervals between selected pairs of signals of the sequence,
whereby, conditions of cardiac pacer failure, non-capture and
intermittent capture of the heart by the cardiac pacer,
cardio-vascular system hemodynamic changes, cardiac arrhythmias
such as missing heartbeat, and possible premature ventricular
contraction are detectable.
16. A cardiac diagnostic system as described in claim 15 wherein
said receiver processer signal presentation means comprises
measuring means effective to automatically measure the time
intervals between selected pairs of signals of the sequence and
provide a read-out of the measurement in units of time.
17. A cardiac diagnostic system as described in claim 15 wherein
said first detection means comprises transducer means which
generates a first discrete electrical signal upon detection of each
pacer pulse and which generates a second discrete electrical signal
upon detection of each blood pulse, and wherein said converter
means converts said first and second discrete electrical signals
respectively into first and second signals of different frequency
and combines said signals of different frequency into a single
sequence.
18. A cardiac diagnostic system as described in claim 16 wherein
said measuring means comprises sorting means effective to separate
the timed sequence of signals into a first sequence of signals
corresponding only to pacer pulse signals and a second sequence of
signals corresponding only to blood pulse signals.
19. A cardiac diagnostic system as described in claim 16 wherein
said measuring means read-out includes an electrical signal
read-out representing the time interval just measured, and said
receiver processer further includes a comparator device coupled to
said measuring means and effective responsive to said electrical
signal read-out from the latter to actuate an alarm when the time
interval represented thereby differs by more than a predetermined
amount from a standard time interval selectively programmed into
said comparator device.
20. A cardiac diagnostic system as described in claim 17 wherein
said receiver processer signal presentation means comprises
measuring means effective to automatically measure the time
intervals between selected pairs of signals of the said single
sequence of signals and provide a read-out of the measurement.
21. A cardiac diagnostic system as described in claim 20 wherein
said measuring means comprises sorting means effective to separate
said signals of different frequency in said single sequence of
signals into a first sequence of signals corresponding only to
pacer pulse signals and a second sequence of signals corresponding
only to blood pulse signals.
22. A cardiac diagnostic system as described in claim 21 wherein
said measuring means includes selection means for measuring the
time intervals between one or more of the following:
a. each successive pair of signals of said first sequence,
b. each successive pair of signals of said second sequence,
c. each successive pair of signals in which the first signal of the
pair is selected from said first sequence and the second signal of
the pair is selected as the next occurring signal from said second
sequence.
Description
This invention relates to a cardiac diagnostic system, and more
particularly relates to a diagnostic system for providing follow-up
care to persons with implanted cardiac pacers by use of the
ordinary telephone without requiring frequent patient visits to the
cardiologist.
Cardiac pacers are devices which generate electrical impulses at a
recurring rate for the purpose of stimulating the heart muscle to
produce normal contractions at a regularly recurring rate in the
manner of a normal heart which does not require external electrical
stimulation. Cardiac pacers are subject to malfunction by reason of
defective parts, battery depletion, and improper conduction of the
pacer pacing pulses to the heart muscle due to perhaps a broken
electrical lead or a shift of an electrode with respect to the
heart muscle itself. In the latter case, it is of course possible
for the pacer to itself be functioning in a perfectly proper manner
while at the same time being completely ineffective insofar as the
performance of its vital function is concerned.
In the past, pacer testing has generally been concerned with
attempting to determine whether the pacer is generating its pulse
properly, or whether the pulse has deteriorated, usually due to
battery depletion. It will be appreciated that a check of pacer
pulse performance, while a necessary condition, is not of itself
sufficient to insure that the heart of a cardiac patient is in fact
being properly paced by the pacer. The system according to the
invention provides a simple, inexpensive, convenient and reliable
means for quickly determining whether or not the implanted pacer is
itself functioning properly and whether or not the cardiac patient
is properly responding to the pacer. Specific immediate or
incipient problems are immediately detectable, as for example a
condition of only intermittent capture of the heart by the pacer a
condition of no capture, hemodynamic changes in the circulatory
system of the patient, and possible premature ventricular
contractions. These physiological conditions are all possible even
though the pacer mechanism itself is functioning perfectly, and
their early detection can lead to immediate examination by a
cardiologist to determine exactly what is happening to the patient
so that corrective steps may be taken at a time when they will be
effective.
Briefly, the system includes a very small lightweight transducer
transmitter device which is in the possession of the patient, and a
receiving device which is located at a data processing center which
may be in a clinic or at a central processing office. In accordance
with a time schedule as determined by the patient's physician, or
on an emergency basis, the patient places a telephone call to the
processing center, places the telephone headset properly with
respect to the transmitter and grasps the transducer transmitter
electrodes. The electrical pacer pulse and the subsequent
physiological blood pulse of the patient are both picked up by the
electrodes, processed in the transmitter and then transmitted out
over the telephone line to the data processing receiver center
where the information may be processed in a number of different
ways to give a complete picture of what is actually happening to
the patient.
The results of the processed information are immediately available
and the patient can be informed at that time via the telephone
connection that every thing is in order or that the patient should
be in contact with his or her physician. In the latter event, the
physician is of course immediately contacted by the data processing
unit and informed of the result of the check just carried out so
that the doctor is alerted to the need for taking some action. The
data recorded in tangible form at the processing center is
immediately transmitted to the physician for his own personal
evaluation.
It is a primary object of the invention to provide a novel cardiac
diagnostic system by means of which the condition of an implanted
cardiac pacer and the physiological responses of the body thereto
can be quickly determined by remotely located diagnostic equipment
made available to the patient via the ordinary commercial telephone
system.
Another object of the invention is to provide a novel cardiac
diagnostic system as aforesaid which utilizes a small lightweight
transducer device retained by the cardiac patient and by means of
which the requisite diagnostic information is obtained from the
patient and transmitted into the telephone system.
A further object of the invention is to provide a novel cardiac
diagnostic system as aforesaid wherein the transducer apparatus
processes the electrical pacer pulses and the physiological patient
blood pulses to provide time related electrical signals from which
a diagnosis of the functioning condition of the pacer and the
physiological cardiac condition of the patient are quickly
determinable.
The foregoing and other objects of the invention will become clear
from reading the following specification in conjunction with an
examination of the appended drawings, wherein:
FIG. 1 is a pictorial diagrammatic representation of the
transmitting portion of the system and a representative part of the
receiving portion of the system according to the invention;
FIG. 2 is a functional block diagram of the apparatus utilized in
the diagnostic system for effecting a complete cardiac diagnosis
according to the invention; and
FIG. 3A to 3I is a nine part timing diagram illustrating the
general form of information derived from the cardiac patient and
the subsequent processing thereof together with illustrations of
various types of conditions which can occur and which are
detectable for diagnosis.
In the several figures, like elements are denoted by like reference
characters.
Referring now to the drawings, and first to FIG. 1 and 2, there is
seen the transducer transmitter designated generally as 10 and the
data receiver and processor designated generally as 11 which are
intercoupled by the commercial telephone system designated
generally at 12 and terminating at the transmitting and receiving
ends respectively with the hand sets 13 and 14.
The transducer transmitter 10 is held in a suitable flat hinged
case 15 having a battery power supply 16 which energizes the
circuitry of the device through switch 17 when the case 15 is
opened, and which disconnects the power supply from the circuitry
when the case is closed. The electronic processing apparatus
contained within the region 18 of the case 15 includes amplifiers
19 and 20 which are respectively fed signals from pacer pulse
pick-up electrode 21 and blood pulse pick-up electrode 22 through
signal cables 23 and 24. Amplifier 19 amplifies the electrical
pacer pulse to insure the triggering of a monostable trigger
circuit 25 which generates a square pulse 26 which is then
differentiated and clipped by differentiater clipper 27 to provide
a sharp pulse 28 from the leading edge of square pulse 26 while
suppressing the sharp pulse generated by the trailing edge of
square pulse 26. The blood pulse amplified by amplifier 20 is used
to trigger a triggered oscillator 29 to provide a timed burst of
audio frequency oscillation 30 which might typically be on the
order of two thousand to twenty-five hundred Hertz. The derived
pacer pulse 28 and audio burst 30 are, as will be subsequently
seen, routed to speaker driver 31 in temporally spaced sequence and
are then converted to audio signals by the loud speaker 32 which
transmits them through a sound tunnel 33 to the transmitter 34 of
telephone hand set 13.
Since the heart muscle contracts in response to the electrical
pacer pulse, the order of events is such that the electrical pacer
pulse is generated first and is then followed by the blood pulse
resulting from contraction of the heart muscle. The blood pulse can
be picked up at any convenient point on the body such as the nose,
forehead or a finger or toe, and the time interval between
contraction of the heart muscle and pick-up of the blood pulse is
determined by the distance between the heart and the point at which
the blood pulse is picked up. As illustrated, the finger is a
convenient point for pick-up and a suitable finger pulse pick-up
device typically could be that manufactured by the Sanei Instrument
Company of Japan which is sensitive to shifts in the red spectrum
and produces a voltage change with variations in blood flow. The
timing intervals to be hereafter mentioned in connection with the
timing diagram of FIG. 3 are all intervals which would occur for
blood pulses which are detected at the fingers of the patient.
The train of signals 28 and 30 after injection into the transmitter
34 of telephone hand-set 13 proceed through the telephone system 12
to the receiver 35 of the telephone hand-set 14 at the data
processing center where they are amplified by telephone amplifier
36 and transmitted via cable 37 to one or more pieces of terminal
equipment, such as to loudspeaker 38 via cable 39 for the
generation of audible signals in the form of a tick representing
the pacer pulse followed by a tone representing the blood
pulse.
The terminal equipment of more significance however would be the
strip recorder 40 of the moving stylus type and the interval
counter 41 which typically could be a Monsanto 100B counter. The
interval counter is a device which provides a read-out of the time
interval between selected events. For example, a digital read-out
can be obtained for the time interval between successive derived
pacer pulse spikes 28 in order to determine the pacer pulse rate
and whether or not the rate is constant within the allowed
tolerance limits. The counter can also be selectively set to
determine the same information for pulses derived from the burst 30
of audio frequency signal which corresponded to the occurrence of
the physiological blood pulse of the patient. Additionally, and of
great importance, is the measurement of time interval between the
occurrence of a derived pacer pulse 28 and a pulse corresponding to
the occurrence of the physiological blood pulse. Since the
information on cable 37 is in fact the pacer pulse 28 and the audio
tone 30, two things must be done in order to properly present the
data to the interval counter 41.
First, the derived pacer pulse 28 must be separated from the audio
burst 30 with the former being permitted to pass to the interval
counter 41 while the latter is suppressed. This is carried out by
the high pass filter 42 which passes the derived relatively high
frequency pacer pulse 28 while supressing the relatively lower
frequency tone burst 30 so that the input to interval counter 41 on
line 43 consists only of the succession of derived pacer pulses
28.
Secondly, the audio tone burst 30 must be separated from the
derived pacer pulse 28 and converted into a pulse input of suitable
waveform for use as a signal input to the interval counter 41. This
is accomplished by the demodulator 44 which envelope detects the
low frequency tone burst 30 while suppressing the relatively high
frequency derived pacer pulse 28, and the differentiator clipper 45
which produces a derived blood pulse 46 from the leading edge of
the demodulated audio burst signal while clipping the trailing edge
pulse. The derived blood pulse 46 is injected at the interval
counter 41 via the signal input line 47.
The interval counter 41 is provided with an output signal
connection which provides an output signal that changes from a
logical "one" to a logical "zero" when the count is started and
reverses when the count is terminated, thus providing a step
function output which may be applied to integrator 57. Should the
count exceed a predetermined set value, the integrated output
signal level reaches a magnitude sufficient to trigger the Schmitt
trigger 58 and actuate an alarm 59 of whatever type is desired.
The elements shown in the functional block diagram of FIG. 2 are
all well known and need not be described in detail, and any
functionally equivalent particular form of element would be equally
suitable. For example, the demodulator 44 need not be an envelope
detector, but could for example be a high Q filter tuned to the
audio burst frequency 30 and followed by a suitable form of trigger
circuit and differentiator to produce the desired derived blood
pulse 46. The particular form of demodulator 44 is not significant,
it is the signal separating the waveshaping function which is of
importance.
Turning now to a consideration of the timing diagrams of FIG. 3, it
is observed that nine timing times A through I are illustrated,
depicting various diagnostic conditions to be now described.
The diagram 3A shows a repetitive sequence of pulse waveforms
beginning with a relatively high amplitude wave having a steep
leading edge, and followed by two waveforms of low amplitude with
the pattern being thereafter successively repeated. The high
amplitude wave designated as 48 corresponds to the R-wave of the
EKG tracing of a typically paced heart, while the succeeding low
amplitude waves 49 and 50 represent respectively the T-wave and the
P-wave. The steeply rising leading edge of the R-wave occurs
immediately after the time of the pacer pulse spikes designated as
28 in FIGS. 3C and 3E through 3I although the time scale is such
that the separation is not visible. These pacer pulse spikes are
observed to occur at the times designated as t.sub.o, t.sub.2 and
t.sub.4. FIG. 3B illustrates the general form of the blood pulse
waveform picked up at the finger by the finger pulse pick-up 22,
and these are also observed to be cyclically repetitive and occur
at times t.sub.1 and t.sub.3. In a normal situation, the time
interval (t.sub.1 - t.sub.o) will be equal to (t.sub.3 - t.sub.2)
and will be approximately 0.6 seconds .+-. 0.15 seconds.
FIG. 3C illustrates the derived pacer pulses 28 as previously
described with the intervals (t.sub.2 - t.sub.o) = (t.sub.4 -
t.sub.2) = .DELTA.t .+-. 0.3 milliseconds where the time interval
.DELTA.t is chosen by the physician with respect to the particular
patient and will lie normally within the range of 500 to 1,200
milliseconds. FIG. 3D illustrates the tone bursts 30 derived from
the blood pulse waveforms 51 illustrated in FIG. 3B, these bursts
30 occuring at time intervals (t.sub.3 - t.sub.1) which should be
equal to the previously defined .DELTA.t .+-. approximately 30
milliseconds.
The showing of FIG. 3E is a combination of the waveforms of FIG. 3C
and FIG. 3D showing the normal pattern of occurrance of a pacer
pulse followed at the appropriate time by a blood pulse with the
two signals repeating cyclically over and over as shown. Such a
pulse pattern of course illustrates a properly functioning cardiac
pacer putting out its pulses at the proper time and resulting in
complete capture of the heart muscle with the consequent regular
rhythmic contractions of the heart producing the desired blood
pulse pattern.
The timing patterns of FIG. 3F through FIG. 3I illustrate abnormal
conditions which are detectable by the cardiac diagnostic system
according to the invention. These abnormal conditions are usually
detectable at a sufficiently early point in time so that remedial
action can be taken before the development of any critical
condition occurs. FIG. 3F illustrates a regularly occurring series
of pacer pulses 28 in which the first and third pulses are followed
by pulses 46 corresponding to the occurrence of blood pulses.
However, it is observed that there are no blood pulses 46 following
the second and fourth pacer pulses 28, indicating that the second
and fourth pacer pulses 28 were ineffective in causing a
contraction of the heart muscle. This type of pulse pattern
indicates only intermittent capture of the heart by the cardiac
pacer, and also indicates the patient should immediately consult
his cardiologist because such a pattern indicates either
physiological changes requiring attention or some problem
associated with proper transfer of the pacer pulse to the heart
muscle. The regularity of the pacer pulses 28 of course rules out
any malfunction of the electrical circuitry of the cardiac pacer
itself.
FIG. 3G discloses a pattern of regularly occurring equally spaced
pacer pulses 28 together with a series of three blood pulse signals
52a, 52b and 52c which respectively follow the first, second and
fourth pacer pulses. It will be observed that the spacing of the
pulses 52a, 52b and 52c with respect to their immediately preceding
pacer pulses 28 is of a random time nature, and that there is no
blood pulse signal whatever following the third pacer pulse 28. The
missing blood pulse and random blood pulse intervals indicate a
condition of no capture of the heart muscle by the cardiac pacer.
This is a serious condition and must be remedied at the earliest
possible time.
FIG. 3H again illustrates a regularly occurring sequence of pacer
pulses 28 followed however by a regularly occurring series of blood
pulses 53, one such pulse 53 occurring after each pacer pulse 28.
However, comparison of the timing diagram of FIG. 3H with that of
FIG. 3E discloses that the blood pulses 53 are occurring at a much
earlier time after the occurrence of a pacer pulse, and in fact as
shown in FIG. 3H with an interval of (t.sub.1 - t.sub.o) of
approximately 0.5 seconds. The regularity of occurrence of the
blood pulses 53 with respect to the pacer pulses 28 indicates that
complete capture of the heart muscle by the pacer exists, but that
some hemodynamic change has occurred within the physiological
system of the cardiac patient which has shortened the time interval
within which the heart muscle responds to the cardiac pacer pulse.
In this case, the patient will also be referred to his physician so
that a determination can be made as to the significance of the
changed conditions with respect to the particular patient involved.
Such a change may or may not be the forerunner of a serious
condition and can only be determined by a thorough medical
diagnosis.
FIG. 3I illustrates a normally functioning cardiac pacer properly
generating a sequence of pacer pulses 28 in which the seocnd, third
and fourth pacer pulses 28 are followed by regularly occurring
blood pulses 54 temporally spaced from the preceding pacer pulse by
equal amounts. However, it is observed that the first pacer pulse
28 is followed by a pair of blood pulses 55 and 56 instead of by
only a single blood pulse, and that both of the blood pulses 55 and
56 are temporally spaced from the preceding pacer pulse 28 by time
intervals which are different from the time interval of blood
pulses 54 which follow the subsequent pacer pulses 28. The first
blood pulse 55 is one which occurs independently of the pacer pulse
28 while the second blood pulse 56 is caused by the pacer pulse 28
but is delayed in time due to the occurrence of the immediately
preceding blood pulse 55. This condition could indicate possible
premature ventricular contraction which could be the first
indicator of the incipient onset of ventricular fibrillation, and
again represents a condition requiring the attention of the
attending physician.
From the foregoing discussion of the timing diagrams of FIG. 3, it
will be appreciated that merely checking the implanted cardiac
pacer itself to determine whether or not it is generating pacer
signals, while necessary, is totally inadequate as a determinant of
the condition of the patient's cardiac system since all of the
problem conditions just described in connection with the showings
of FIGS. 3F through 3I in fact occur under circumstances where the
electrical cardiac pacer is to all intents and purposes properly
generating its pacing pulses. Accordingly, it should now be
understood that the cardiac diagnostic system according to the
invention enables rapid and early diagnosis of incipient cardiac
problems before they actually become troublesome so that remedial
measures can be immediately undertaken to anticipate and avoid the
occurrence of serious or even fatal cardiac conditions.
Patients without cardiac pacer can use just the blood pulse
detecting features, to transmit information to the data center
which can be used to determine the presence of cardiac arrhythmias.
This can be especially significant for the post coronary patient.
Moreover, detection of the existence of a patient's "R" wave can
also be provided by using an R-wave sensing circuit in the
amplifier 19 in conjunction with the blood pulse detection to
provide data, via the telephone, as to the sequence of mechanical
and electrical events of the cardiac system for patients without
pacemakers.
Specifically, the complete EKG will not be transmitted, only the
timing of the R wave to R wave interval is necessary, so only a
pulse corresponding to the R wave need be transmitted, as is done
with the pacer spike.
Having now described the invention in connection with a
particularly illustrated embodiment thereof, it will be appreciated
that variations and modifications of the invention may now occur
from time to time to those persons normally skilled in the art
without departing from the essential scope or spirit of the
invention, and accordingly it is intended to claim the same broadly
as well as specifically as indicated by the appended claims.
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